The Impact of the Use of Recombinant Human Growth Hormone on ADHD Characteristics in Children and Adolescents

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Brief Title

The Impact of the Use of Recombinant Human Growth Hormone on ADHD Characteristics in Children and Adolescents

Official Title

The Impact of the Use of Recombinant Human Growth Hormone on Attention Hyperactivity Deficit Characteristics in Children and Adolescents

Brief Summary

      Analysis of the short-and long-term impact of recombinant growth hormone on attention deficit
      and hyperactivity charachteristics in children and adolescents. This will be examined in
      children prior to GH therapy and 3, 6 and 12 months during treatment, by filling validated
      questionnaires (Vanderbilt rating scales) evaluating ADHD.

      Data will be compared to healthy control group.
    

Detailed Description

      Background The main objective of this study is to analyze the short-and long-term influence
      of recombinant growth hormone on clinical and questionnaires based criteria of attention
      deficit/hyperactivity disorder in children and adolescents. This will be examined in children
      prior to GH therapy and 3, 6 and 12 months during treatment, by filling validated
      questionnaires (Vanderbilt rating scales) evaluating ADHD. All participants will be treated
      by rhGH doses acceptable by the FDA recommendations.

      Trial Goal The main goal of this trial is to assess if there is any association between
      treatment with rhGH during a short period of 3 months, or a long period of 3-12 months and
      the development of characteristics of ADHD (measurable parameters )

      Hypothesis Our research hypothesis, is that although parents fear of hyperreactive symptoms
      after rGH administration, our study will demonstrate that providing regular management of
      recombinant human growth hormone therapy over time, will not be associated with significant
      change in attention deficit/hyperactive characteristics compared to matched age and sex
      controls who did not receive GH treatment. This prospective case control study format study
      has been chosen in order to observe and document any behavioural influence with the
      recommended and standard treatment with GH treatment given according to current guidelines.

      Study population and size were decided according to a statistician calculation of 80% power
      and 5% significance and with a consiideration of 15% drop-out

      Trial design An open prospective observational case control study that will recruit children
      and adolescents prior to initiation of GH treatment. This is a single-site study, however
      patients who comply with inclusion and exclusion criteria, may be recruited by the media, by
      representatives of pharmaceutical companies, medical associations and the Children's
      Endocrinology Association. Every eligible participant, wherever treated for his condition may
      take part in the study.

      The study design is to compare, in a controlled case-control manner, prospectively. The
      development of ADHD characteristics in a group of patients from initiation to 12 months of
      treatment with rhGH compared to a similar gender and age controlled group, not treated by
      rhGH.

      Statistical Analysis All data will be presented in mean ,min and max. The data will be
      divided according to age and results.

      Statistical analysis will be performed by ANOVA with repeated measures, which will examine
      the difference between the trial and control group, at the 4 different time points, as well
      as the difference in each patient for itself, the influence of time and the interaction
      between these measures.
    


Study Type

Observational


Primary Outcome

ADHD criteria


Condition

Growth Hormone Deficiency

Intervention

Questionnaires

Study Arms / Comparison Groups

 GH treated patients
Description:  All participants family member and teacher will fill questionnaires regarding signs of ateention deficit prior to GH treatment and after 6 and 12 months

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

100

Start Date

January 2015

Completion Date

December 2020

Primary Completion Date

December 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Children over the age of 6 years, and less than 16 years

          -  Children eligible for rhGH treatment according to the following Food and Drug
             Administration approved indications; Small for gesational age, Idioapathic short
             stature, GH deficiency and chronic renal failure.

          -  Consent of parents / guardian to participate in research

        Exclusion Criteria:

          -  - Under the age of 6 years and above 16 years

          -  Previously diagnosed with neurocognitive disease

          -  Previously diagnosed with specific syndromes: Prader-willi syndrome, Turner

          -  Previously diagnosed with Attention Deficit/Hyperactivity disorder
      

Gender

All

Ages

6 Years - 16 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

marianna Rachmiel, md, 97289542007, [email protected]

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT02973061

Organization ID

240/14


Responsible Party

Sponsor

Study Sponsor

Assaf-Harofeh Medical Center


Study Sponsor

marianna Rachmiel, md, Principal Investigator, Assaf Haroffeh Medical Center


Verification Date

August 2019